UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013021 |
|---|---|
| Receipt number | R000014943 |
| Scientific Title | The clinical stydy of the relationship between polyunsaturated fatty acid levels and obesity in diabetic patients |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2014/01/30 18:13:07 |
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Basic information
Public title
The clinical stydy of the relationship between polyunsaturated fatty acid levels and obesity in diabetic patients
Acronym
Polyunsaturated fatty acid and obesity
Scientific Title
The clinical stydy of the relationship between polyunsaturated fatty acid levels and obesity in diabetic patients
Scientific Title:Acronym
Polyunsaturated fatty acid and obesity
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the blood unsaturated fatty acid levels associate with obesity in type 2 diabetic patients.
Basic objectives2
Others
Basic objectives -Others
To investigate whether the analysis of the blood unsaturated fatty acid levels associate with obesity in type 2 diabetic patients.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between palsma unsaturated fatty acid levels
and obesity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 dibetic patients without taking EPA agents.
Key exclusion criteria
Type 1 diabetic patients, and type 2 patients with taking EPA agents.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MARIKO HIGA |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
3-6-1 Shimosueyoshi Tsurumi-ku Yokohama-shi
TEL
045-576-3000
mariko-h@wb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MARIKO HIGA |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
3-6-1 Shimosueyoshi Tsurumi-ku Yokohama-shi
TEL
045-576-3000
Homepage URL
mariko-h@wb3.so-net.ne.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Tobu Hospital
Department of Diabetes and Endocrinology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no particular problem.
Management information
Registered date
| 2014 | Year | 01 | Month | 30 | Day |
Last modified on
| 2014 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014943
